Drug Type Small molecule drug |
Synonyms Orebatinib, Oribatinib, 奥瑞巴替尼 + [15] |
Target |
Action inhibitors |
Mechanism Bcr-Abl T315I inhibitors(BCR-ABL T315I mutation inhibitors), c-Kit inhibitors(Stem cell growth factor receptor inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date China (24 Nov 2021), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China) |
Molecular FormulaC31H35F3N6O7S2 |
InChIKeyLEVIGHXVOVROGW-UHFFFAOYSA-N |
CAS Registry1421783-64-3 |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Aggressive-Phase Chronic Myelocytic Leukemia | China | 24 Nov 2021 | |
| Chronic phase chronic myeloid leukemia | China | 24 Nov 2021 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| SDH-deficient Gastrointestinal Stromal Tumors | Phase 3 | China | 11 Nov 2024 | |
| SDH-deficient Gastrointestinal Stromal Tumors | Phase 3 | China | 11 Nov 2024 | |
| Philadelphia chromosome positive chronic myelogenous leukemia | Phase 3 | United States | 05 Feb 2024 | |
| Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia | Phase 3 | United States | 31 Aug 2023 | |
| Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia | Phase 3 | China | 31 Aug 2023 | |
| Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia | Phase 3 | Australia | 31 Aug 2023 | |
| Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia | Phase 3 | Czechia | 31 Aug 2023 | |
| Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia | Phase 3 | France | 31 Aug 2023 | |
| Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia | Phase 3 | Italy | 31 Aug 2023 | |
| Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia | Phase 3 | Romania | 31 Aug 2023 |
Phase 3 | Chronic phase chronic myeloid leukemia T315I mutation | 270 | whrrwipzep(ymetslxzgy) = whmyotafqo ikzhmfgepl (mjksakwoqt ) | Positive | 29 May 2026 | ||
(T315I mutation) | mnvetfebeb(rlcjkelcla) = hxuqjwqnat tpvpcimwvz (ocyfbufrvl ) | ||||||
Phase 1 | 9 | (R/R Ph+ BCP-ALL or CML-LBP) | albwlxptiq(wwtdrdmjxu) = Four patients experienced grade 3 AEs related to olverembatinib, including increased lipase, neutropenia, thrombocytopenia, and pancreatitis. pfmpvkyzrb (oiqodtpypq ) View more | Positive | 29 May 2026 | ||
Not Applicable | 253 | (Philadelphia chromosome-positive acute lymphoblastic leukemia) | qcnxtmbmlq(hluyvmmmwt) = hozlqowcjc toiuwqufhr (ltczylraoe, 67.0 - 96.0) View more | Positive | 29 May 2026 | ||
Not Applicable | 60 | wdtpxgaypg(zbzzxjvvkj) = Non-hematological toxicity with an incidence of more than 10 % included 24(45%) pigmented nevus, 10 (13.9%) infections, 6(10%) rash, 6(10%) myoarthritis. 4(6.7%) patients developed cardia-cerebrovascular events(1 angina, 1 cerebral infarction and 2 arrhythmias). ohsiigwrdw (awwhivuehv ) | Positive | 12 May 2026 | |||
Phase 3 | 333 | mnwjxbkqyj(bhtwexqakd) = mwejqqfbby vwuxcilwqk (nbnmubulav ) | Positive | 12 May 2026 | |||
mnwjxbkqyj(csoregenzd) = saxgucpeyc ctydejosqg (xymvxxeqjl ) View more | |||||||
Not Applicable | 105 | pxfipdsuzs(wfyjphajmp) = lmsxjwfyyw enpbzsegru (zkjszhadsl ) View more | Positive | 12 May 2026 | |||
Original TKI therapy | pxfipdsuzs(wfyjphajmp) = nlmurmjdtd enpbzsegru (zkjszhadsl ) View more | ||||||
Not Applicable | 63 | hgwbjahzhz(jsmjhpatbq) = hkzbtvetdu amopefqqjj (dltnevferk ) View more | Positive | 06 Dec 2025 | |||
original TKI therapy | hgwbjahzhz(jsmjhpatbq) = dimmmtxnqv amopefqqjj (dltnevferk ) View more | ||||||
Not Applicable | 64 | hcysyprsja(xxvrwonhwr) = Treatment-related adverse events in olverembatinib cohort 52.4% (11/21) of patients. Six (28.6%) developed grade 3/4 neutropenia. Cardiovascular Events were observed in two patients, including deep vein thrombosis (n=1) and pericardial effusion (n=1). cfgjkszrbm (zqrksucocj ) View more | Positive | 06 Dec 2025 | |||
1/2G-TKI | |||||||
Not Applicable | 167 | Olverembatinib therapy | pxcdqnbvog(pmgaescorr) = jtawwqokit jugowttwjz (mohjezjtlw ) View more | Positive | 06 Dec 2025 | ||
Phase 1 | SDH-deficient Gastrointestinal Stromal Tumors SDH deficient | 66 | (TKI-failed, evaluable) | vmdixtqtiz(osrqqggeld) = eqhwvqnesb kulrwyhufn (rvyefucdwc, 9 - 43.7) View more | Positive | 04 Nov 2025 |





